Back to Agenda
Real World Evidence: How Does its Use Challenge Quality and Compliance Programs?
Session Chair(s)
Kassa Ayalew, MD, MPH
Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States
Evaluation of real world evidence (RWD) in the context of regulatory decision making depends not only on the evaluation of the methodologies used to generate the evidence, but on the reliability and relevance of the underlying RWD. FDA uses on-site inspections and data audits to evaluate all aspects of the conduct and reporting of FDA regulated research including data derived in real world settings. Speakers will provide views from regulatory perspective.
Learning Objective : Discuss the importance of reliable data derived from sources other than traditional clinical trials to support regulatory decision making; Identify factors that FDA considers for assessing the reliability of real world data through on site inspections.
Speaker(s)
CPRD Update
Clinical Operations Manager, The Clinical Practice Research Datalink Group (CPRD); MHRA, United Kingdom
FDA Update
Director, Division of Clinical Compliance Evaluation, OSI, OC, CDER, FDA, United States
Industry Update
CEO, CRIO, United States
Have an account?